Cardiome/Astellas' RSD1235 gets FDA "refusal to file" letter

Canada's Cardiome Pharma says that its co-development partner, Astellas Pharma US, has received "refusal to file" letter from the US Food & Drug Administration for the New Drug Application for RSD1235, an investigational new drug for the acute conversion of atrial fibrillation.

In accordance with application regulations, the FDA is required to accept or refuse an application within 60 days of the completion of the filing, which occurred on March 31, 2006. Neither the acceptance nor non-acceptance of the NDA filing is a determination of the approvability of RSD1235, says Cardiome.

"We are very disappointed to communicate this setback to our stakeholders," said Doug Janzen, president of Cardiome, adding: "based on the clinical data generated from this program, we had great confidence that the submission would have met the agency's filing requirements. Following this FDA decision, we will engage in discussions with our partner seeking greater involvement in the regulatory pathway."